Simplify the job of creating, managing and reviewing eCTD submissions.
Pharmaceutical and biopharmaceutical companies need to make sure they are managing their electronic Common Technical Document (eCTD) submissions as effectively as possible. DXC eCTDXPress, part of DXC’s Publishing Software Suite, is a solution for creating, managing and reviewing eCTD life cycles. It satisfies regulatory agency and industry sponsor requirements for assembling, reviewing, compiling, validating, publishing and archiving worldwide eCTD submissions.
As the leading electronic submission product used by pharmaceutical and biopharmaceutical companies, eCTDXPress is a scalable solution that simplifies the job of creating, managing and reviewing eCTD life cycles. With an advanced architecture, eCTDXPress can be deployed to meet the needs of companies of all sizes and at all levels of eCTD-adoption maturity. A modular approach allows companies to independently add newly supported regions to their systems and adapt to new markets without affecting existing regions.
To simplify a company’s technology infrastructure burdens and increase the speed and efficiency of regulatory submissions, eCTDXPress leverages Microsoft .NET technology. In addition to its intuitive design, the application also takes a cost-effective deployment approach and requires measurably reduced validation efforts.
Key benefits of eCTDXPress:
Simplicity and efficiency: The step-by-step wizards of eCTDXPress take your company through the entire process, eliminating time spent manually processing eCTDs. This reduces learning curves, minimizes training requirements and helps eliminate costly errors. Moving from a non-eCTD format or paper format to an eCTD format is easy, because eCTDXPress can import from various sources and create the eCTD backbone, complete with hyperlinked and bookmarked documents. This gives companies a head start for future eCTD applications.
Best performance, best price: eCTDXPress provides a central desktop platform to minimize disruption to existing IT infrastructure and reduce costs. The system architecture makes multiregional or global deployments of eCTDXPress easier and less expensive than traditional applications because it reduces installation and maintenance requirements. The standards-based architecture lowers the complexity and cost of typical infrastructure design and minimizes the installation footprint when other components are added.
Local collaboration, global functionality: eCTDXPress lets users collaborate with local operating companies and develop reusable, core dossiers for easy, local adoption of eCTDs by regional health authorities. eCTDXPress also delivers on a global level, providing functionality such as inherited metadata from one sequence or many, as well as support for multiple languages. eCTDXPress offers performance upgrades to handle the creation and life cycle management of eCTDs in the United States, Europe, Japan, Canada, South Africa, Australia, Saudi Arabia and the Swiss Agency for Therapeutic Products (Swissmedic).
Key features of eCTDXPress:
Intuitive eCTD submissions: eCTDXPress eliminates or eases manual processes and duplication of work — such as reviews, data entry, bookmarking and hyperlinking — with increased automation and electronic capabilities. An intuitive user interface can be customized to suit preferences, layouts and regional eCTD settings. eCTDXPress comes with built-in templates, tools and automatic updates of multiregional requirements.
Simultaneous eCTDs: eCTDXPress enables simultaneous access to the same application by multiple users and provides capabilities to automatically update and adjust file names based on regional requirements or eCTD formats.
Flexible delivery options: eCTDXPress can be deployed to meet the needs of companies of all sizes and at all levels of eCTD adoption maturity. The product can also be delivered as a scalable enterprise solution, as a hosted software-as-a-service (SaaS) solution, or as a packaged, scalable, entry-level desktop solution. DXC delivers its SaaS solution as a prebuilt, fully qualified virtual environment using VMware technology, allowing for a cost-effective, single-tenant SaaS model.
Powerful metadata management: eCTDXPress incorporates robust metadata in a single, centralized repository. From a single interface, eCTDXPress enables users to seamlessly access and track all metadata (custom, document, study and region) during the life cycle of a compound. Users can view, sort, transfer and link all metadata in a single submission or related submissions. Real-time tracking and modification of metadata creates efficiencies in the submission process, significantly reducing the time for eCTD assembly.
